For Industry

How does the Tobacco Control Act define substantial equivalence?

"Substantially equivalent" or "substantial equivalence," as defined by Section 910(a)(3)(A) of the Tobacco Control Act, refers to a product that:

"Has the same characteristics as the predicate tobacco product; or"

"Has different characteristics and the information submitted [in a Substantial Equivalence Report] contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under [the new tobacco product application provisions of section 910(c)] because the product does not raise different questions of public health."